echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Medical Research Articles > FDA grants Corchi bio-whole BCMA CAR-T cell (CT053) "orphan drug" qualification

    FDA grants Corchi bio-whole BCMA CAR-T cell (CT053) "orphan drug" qualification

    • Last Update: 2020-06-08
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

    recently, cozie bio
    pharmaceutical(http://(Shanghai) limitedcompany(http://(CARsgen Therapeutics) announced that the U.SFoodmedicine s(http://Regulatory Authority (US
    FDA(http://) granted itsproduct son(http://for the treatment of multiple myeloma CAR-T cell (CT053) "orphan drug" qualification   The FDA's accreditation of 'orphan medicine' is an important regulatory milestone in the development and commercialization of CT053, which is currently undergoing registered clinical research in China, including Chaoyang Hospital in Beijing and First Hospital affiliated with Suzhou University, said Dr Li Zonghai, Chairman, CEO and CSO CT053 was also licensed for clinical trial trials in the United States and Canada in June and July this year, respectively, http:// exploratory Phase I clinical research data show that CT053 has very excellent clinical efficacy and good safety, and 19 of the 24 patients with recurrent and difficult to treat multiple myeloma reached full remission (total remission rate of 79.2%) and did not have stage 3 and above cytokine release syndrome   Orphan drugs are drug (http:// and biological products used to treat, diagnose, or prevent rare diseases/diseases that affect less than 200,000 people, and are granted by the US FDA Orphan Drug Product Development Office
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.